EC Approves Aflibercept Biosimilar
Formycon AG ( and its licensing partner Klinge Biopharma GmbH) jointly announce that the European Commission has granted central marketing authorization for FYB 203 (Aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama
The approval encompasses the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO). The decision of the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from November 2024 and applies to all countries in the European Economic Area (EEA), including the 27 member states of the European Union (EU) as well as Iceland, Liechtenstein, and Norway.
Dr. Stefan Glombitza, CEO of Formycon AG, commented: “The EU approval of FYB 203, our biosimilar for Eylea, marks another milestone for Formycon and is based on the expertise and dedication of our entire team. As our second ophthalmic biosimilar, FYB 203 significantly expands therapeutic options for patients with severe retinal diseases. With Ahzantive and Baiama, we are improving access to high-quality and affordable therapies that contribute sustainably to enhancing patients’ quality of life.”
Aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, thereby impairing vision. In 2023, the reference product Eylea achieved global sales of approximately $ 9 billion, highlighting the significance and necessity of a cost-effective alternative like FYB 203.
In mid-January 2025, Formycon and Teva Pharmaceuticals International GmbH (Teva) signed a licensing agreement for the semi-exclusive commercialization of FYB 203 across major parts of Europe and Israel.
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